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Spots Global Cancer Trial Database for Minimal SN Tumor Burden

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Trial Identification

Brief Title: Minimal SN Tumor Burden

Official Title: Minitub: Prospective Registry of Sentinel Node (SN) Positive Melanoma Patients With Minimal SN Tumor Burden Who Undergo Completion Lymph Node Dissection (CLND) or Nodal Observation

Study ID: NCT01942603

Interventions

Study Description

Brief Summary: The purpose of this registry is to collect data in order to discover whether melanoma patients with minimal SN tumor burden should undergo a complete lymph node dissection (CLND) or not. Currently, if a patient has a positive (or metastatic) SN, this patient will be offered a CLND, which is a surgical intervention aiming to remove all lymph nodes from the same nodal basin as the SN. However, if the positive (or metastatic) SN is only minimally involved, some centers and/or countries do not offer a CLND routinely. As a matter of fact, the CLND procedure does not increase survival for patients with a minimal SN tumor burden, but can add prognostic information, potentially useful in the subsequent decision-making process. However, this is a surgical operation for the patient, which might be accompanied by significant side effects. Moreover, only approximately 20% of patients with a metastatic SN have further lymph node metastases in the same basin, which means that about 4 patients out of 5 will not benefit from a CLND. Thus, there is an urgent need to identify which SN positive patients could be safely spared from a CLND. It has been demonstrated that breast cancer patients with minimal SN tumor burden can be safely managed with nodal observation only, without performing a CLND. There is evidence that the same situation exists in melanoma as well, but this needs to be validated and this is why we are conducting this registry. The results of this registry will be crucial to establish an accepted standard of care (CLND or nodal observation) for melanoma patients with minimal SN tumor burden.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

U.Z. Leuven - Campus Gasthuisberg, Leuven, , Belgium

CHRU de Lille, Lille, , France

CHU de Nice - Hopital De L'Archet, Nice, , France

Institut Gustave Roussy, Paris, , France

Charite - Universitaetsmedizin Berlin - Campus Mitte, Berlin, , Germany

Universitaetsklinikum - Essen, Essen, , Germany

UniversitaetsMedizin Mannheim, Mannheim, , Germany

Istituto Europeo di Oncologia, Milan, , Italy

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Napoli, , Italy

Istituto Oncologico Veneto IRCCS - Ospedale Busonera, Padova, , Italy

The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands

Erasmus MC Cancer Institute - location Daniel den Hoed, Rotterdam, , Netherlands

Maria Sklodowska-Curie Memorial Cancer Centre, Warsaw, , Poland

The Institute Of Oncology, Ljubljana, , Slovenia

Hospital Clinic Universitari, Barcelona, , Spain

Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland

Royal Bournemouth Hospital, Bournemouth, , United Kingdom

Cambridge University Hospital NHS - Addenbrookes Hospital, Cambridge, , United Kingdom

Guy's and St Thomas' NHS - St Thomas Hospital, London, , United Kingdom

St George's Hospital NHS Trust, London, , United Kingdom

Norfolk And Norwich Hospital, Norwich, , United Kingdom

St Helens & Knowsley NHS Trust - Whiston Hospital, Prescott, , United Kingdom

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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